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01-08-2014 | Original Paper

Development of a risk score for outcome after transcatheter aortic valve implantation

Authors: Moritz Seiffert, Jan-Malte Sinning, Alexander Meyer, Sandra Wilde, Lenard Conradi, Mariuca Vasa-Nicotera, Alexander Ghanem, Jörg Kempfert, Christoph Hammerstingl, Francisco M. Ojeda, Won-Keun Kim, Dietmar H. Koschyk, Johannes Schirmer, Stephan Baldus, Eberhard Grube, Helge Möllmann, Hermann Reichenspurner, Georg Nickenig, Stefan Blankenberg, Patrick Diemert, Hendrik Treede, Thomas Walther, Nikos Werner, Renate B. Schnabel

Published in: Clinical Research in Cardiology | Issue 8/2014

Abstract

Aims

Transcatheter aortic valve implantation (TAVI) is an increasingly common procedure in elderly and multimorbid patients with aortic stenosis. We aimed at developing a pre-procedural risk evaluation scheme beyond current surgical risk scores.

Methods

We developed a risk algorithm for 1-year mortality in two cohorts consisting of 845 patients undergoing routine TAVI procedures by commercially available devices, mean age 80.9 ± 6.5, 51 % women. Clinical variables were determined at baseline. Multivariable Cox regression related clinical data to mortality (n = 207 deaths).

Results

To account for variability related to age and sex and by enrolment site we forced age, sex, and cohort into the score model. Body mass index, estimated glomerular filtration rate, hemoglobin, pulmonary hypertension, mean transvalvular gradient and left ventricular ejection fraction at baseline were most strongly associated with mortality and entered the risk prediction algorithm [C-statistic 0.66, 95 % confidence interval (CI) 0.61–0.70, calibration χ ²-statistic = 6.51; P = 0.69]. Net reclassification improvement compared to existing surgical risk predication schemes was positive. The score showed reasonable model fit and calibration in external validation in 333 patients, N = 55 deaths (C-statistic 0.60, 95 % CI 0.52–0.68; calibration χ ²-statistic = 16.2; P = 0.06). Additional measurement of B-type natriuretic peptide and troponin I did not improve the C-statistic. Frailty increased the C-statistic to 0.71, 95 % CI 0.65–0.76.

Conclusions

We present a new risk evaluation tool derived and validated in routine TAVI cohorts that predicts 1-year mortality. Biomarkers only marginally improved risk prediction. Frailty increased the discriminatory ability of the score and needs to be considered. Risk algorithms specific for TAVI may help to guide decision-making when patients are evaluated for TAVI.

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Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De BM, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M (2012) Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 33:2451–2496PubMedCrossRef

Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, Gohlke-Barwolf C, Boersma E, Ravaud P, Vahanian A (2005) Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 26:2714–2720PubMedCrossRef

Bach DS, Cimino N, Deeb GM (2007) Unoperated patients with severe aortic stenosis. J Am Coll Cardiol 50:2018–2019PubMedCrossRef

Funkat AK, Beckmann A, Lewandowski J, Frie M, Schiller W, Ernst M, Hekmat K, Gummert JF, Mohr FW (2012) Cardiac surgery in Germany during 2011: a report on behalf of the German Society for thoracic and cardiovascular surgery. Thorac Cardiovasc Surg 60:371–382PubMedCrossRef

Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos SP, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le BH, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van BE, Laskar M (2012) Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 366:1705–1715PubMedCrossRef

Genereux P, Head SJ, Van Mieghem NM, Kodali S, Kirtane AJ, Xu K, Smith C, Serruys PW, Kappetein AP, Leon MB (2012) Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. J Am Coll Cardiol 59:2317–2326PubMedCrossRef

Di MC, Eltchaninoff H, Moat N, Goicolea J, Ussia GP, Kala P, Wenaweser P, Zembala M, Nickenig G, Alegria BE, Snow T, Iung B, Zamorano P, Schuler G, Corti R, Alfieri O, Prendergast B, Ludman P, Windecker S, Sabate M, Gilard M, Witowski A, Danenberg H, Schroeder E, Romeo F, Macaya C, Derumeaux G, Maggioni A, Tavazzi L (2013) The 2011–12 pilot European sentinel registry of transcatheter aortic valve implantation: in-hospital results in 4,571 patients. EuroIntervention 8:1362–1371CrossRef

Dewey TM, Brown D, Ryan WH, Herbert MA, Prince SL, Mack MJ (2008) Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement. J Thorac Cardiovasc Surg 135:180–187PubMedCrossRef

Osswald BR, Gegouskov V, Badowski-Zyla D, Tochtermann U, Thomas G, Hagl S, Blackstone EH (2009) Overestimation of aortic valve replacement risk by EuroSCORE: implications for percutaneous valve replacement. Eur Heart J 30:74–80PubMedCrossRef

10.

Rosenhek R, Iung B, Tornos P, Antunes MJ, Prendergast BD, Otto CM, Kappetein AP, Stepinska J, Kaden JJ, Naber CK, Acarturk E, Gohlke-Barwolf C (2012) ESC working group on valvular heart disease position paper: assessing the risk of interventions in patients with valvular heart disease. Eur Heart J 33:822–828 (828a, 828b)PubMedCentralPubMedCrossRef

11.

Sedaghat A, Sinning JM, Vasa-Nicotera M, Ghanem A, Hammerstingl C, Grube E, Nickenig G, Werner N (2013) The revised EuroSCORE II for the prediction of mortality in patients undergoing transcatheter aortic valve implantation. Clin Res Cardiol 102:821–829PubMedCrossRef

12.

Kotting J, Schiller W, Beckmann A, Schafer E, Dobler K, Hamm C, Veit C, Welz A (2013) German aortic valve score: a new scoring system for prediction of mortality related to aortic valve procedures in adults. Eur J Cardiothorac Surg 43:971–977PubMedCrossRef

13.

Pilgrim T, Kalesan B, Wenaweser P, Huber C, Stortecky S, Buellesfeld L, Khattab AA, Eberle B, Gloekler S, Gsponer T, Meier B, Juni P, Carrel T, Windecker S (2012) Predictors of clinical outcomes in patients with severe aortic stenosis undergoing TAVI: a multistate analysis. Circ Cardiovasc Interv 5:856–861PubMedCrossRef

14.

Abdel-Wahab M, Zahn R, Horack M, Gerckens U, Schuler G, Sievert H, Naber C, Voehringer M, Schafer U, Senges J, Richardt G (2012) Transcatheter aortic valve implantation in patients with and without concomitant coronary artery disease: comparison of characteristics and early outcome in the German multicenter TAVI registry. Clin Res Cardiol 101:973–981PubMedCrossRef

15.

Lopez-Otero D, Trillo-Nouche R, Gude F, Cid-Alvarez B, Ocaranza-Sanchez R, Alvarez MS, Lear PV, Gonzalez-Juanatey JR (2013) Pro B-type natriuretic peptide plasma value: a new criterion for the prediction of short- and long-term outcomes after transcatheter aortic valve implantation. Int J Cardiol 168:1264–1268

16.

Carrabba N, Valenti R, Migliorini A, Vergara R, Parodi G, Antoniucci D (2013) Prognostic value of myocardial injury following transcatheter aortic valve implantation. Am J Cardiol 111:1475–1481PubMedCrossRef

17.

Stortecky S, Schmid V, Windecker S, Kadner A, Pilgrim T, Buellesfeld L, Khattab AA, Wenaweser P (2012) Improvement of physical and mental health after transfemoral transcatheter aortic valve implantation. EuroIntervention 8:437–443PubMedCrossRef

18.

Fairbairn TA, Meads DM, Mather AN, Motwani M, Pavitt S, Plein S, Blackman DJ, Greenwood JP (2012) Serial change in health-related quality of life over 1 year after transcatheter aortic valve implantation: predictors of health outcomes. J Am Coll Cardiol 59:1672–1680PubMedCrossRef

19.

Mack MJ (2011) Risk scores for predicting outcomes in valvular heart disease: how useful? Curr Cardiol Rep 13:107–112PubMedCrossRef

20.

Stortecky S, Schoenenberger AW, Moser A, Kalesan B, Juni P, Carrel T, Bischoff S, Schoenenberger CM, Stuck AE, Windecker S, Wenaweser P (2012) Evaluation of multidimensional geriatric assessment as a predictor of mortality and cardiovascular events after transcatheter aortic valve implantation. JACC Cardiovasc Interv 5:489–496PubMedCrossRef

21.

Sundermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T (2011) Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery. Eur J Cardiothorac Surg 39:33–37PubMedCrossRef

22.

Seiffert M, Schnabel R, Conradi L, Diemert P, Schirmer J, Koschyk D, Linder M, Kersten JF, Grosser A, Wilde S, Blankenberg S, Reichenspurner H, Baldus S, Treede H (2013) Predictors and outcomes after transcatheter aortic valve implantation using different approaches according to the valve academic research consortium definitions. Catheter Cardiovasc Interv 82:640–652PubMed

23.

Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Muller C, Grube E, Nickenig G, Werner N (2012) Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol 59:1134–1141PubMedCrossRef

24.

Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A (2005) A global clinical measure of fitness and frailty in elderly people. CMAJ 173:489–495PubMedCentralPubMedCrossRef

25.

Tibshirani R (1997) The lasso method for variable selection in the Cox model. Stat Med 16:385–395PubMedCrossRef

26.

Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW (2011) Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the valve academic research Consortium. J Am Coll Cardiol 57:253–269PubMedCrossRef

27.

D’Agostino RB, Nam BH (2004) Evaluation of the performance of survival analysis models: discrimination and calibration measures. In: Balakrishnan N, Rao CR (eds) Handbook of statistics. Elsevier, Amsterdam, pp 1–25

28.

Hosmer DW, Lemeshow S (2000) Applied logistic regression, 2nd edn. John Wiley & Sons, New YorkCrossRef

29.

Pencina MJ, D’Agostino RB Sr, Steyerberg EW (2011) Extensions of net reclassification improvement calculations to measure usefulness of new biomarkers. Stat Med 30:11–21PubMedCentralPubMedCrossRef

30.

van Houwelingen HC (2000) Validation, calibration, revision and combination of prognostic survival models. Stat Med 19:3401–3415PubMedCrossRef

31.

Puls M, Viel T, Danner BC, Jacobshagen C, Teucher N, Hanekop G, Schondube F, Hasenfuss G, Seipelt RG, Schillinger W (2012) The risk-to-benefit ratio of transcatheter aortic valve implantation in specific patient cohorts: a single-centre experience. Clin Res Cardiol 101:553–563PubMedCentralPubMedCrossRef

32.

Lynn J, Teno JM, Harrell FE Jr (1995) Accurate prognostications of death. Opportunities and challenges for clinicians. West J Med 163:250–257PubMedCentralPubMed

33.

Dworakowski R, Wendler O, Bhan A, Smith L, Pearson P, Alcock E, Rajagopal K, Brickham B, Dew T, Byrne J, Monaghan MJ, Sherwood R, Shah AM, MacCarthy PA (2012) Successful transcatheter aortic valve implantation (TAVI) is associated with transient left ventricular dysfunction. Heart 98:1641–1646PubMedCrossRef

34.

Rodes-Cabau J, Gutierrez M, Bagur R, De Larochelliere R, Doyle D, Cote M, Villeneuve J, Bertrand OF, Larose E, Manazzoni J, Pibarot P, Dumont E (2011) Incidence, predictive factors, and prognostic value of myocardial injury following uncomplicated transcatheter aortic valve implantation. J Am Coll Cardiol 57:1988–1999PubMedCrossRef

35.

Yong ZY, Wiegerinck EM, Boerlage-van DK, Koch KT, Vis MM, Bouma BJ, Henriques JP, Cocchieri R, Piek JJ, de Mol BA, Baan J Jr (2012) Predictors and prognostic value of myocardial injury during transcatheter aortic valve implantation. Circ Cardiovasc Interv 5:415–423PubMedCrossRef

36.

Chorianopoulos E, Krumsdorf U, Geis N, Pleger ST, Giannitsis E, Katus HA, Bekeredjian R (2014) Preserved prognostic value of preinterventional troponin T levels despite successful TAVI in patients with severe aortic stenosis. Clin Res Cardiol 103:65–72PubMedCrossRef

37.

Kefer J, Beauloye C, Astarci P, Renkin J, Glineur D, Dekleermaeker A, Vanoverschelde JL (2010) Usefulness of B-type natriuretic peptide to predict outcome of patients treated by transcatheter aortic valve implantation. Am J Cardiol 106:1782–1786PubMedCrossRef

38.

Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O (2010) Thirty-day results of the SAPIEN aortic Bioprosthesis European outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 122:62–69PubMedCrossRef

39.

Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, Hambrecht R, Sack S, Hauptmann KE, Richardt G, Figulla HR, Senges J (2011) Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J 32:198–204PubMedCrossRef

40.

Cook NR (2007) Use and misuse of the receiver operating characteristic curve in risk prediction. Circulation 115:928–935PubMedCrossRef

41.

Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S (2010) Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363:1597–1607PubMedCrossRef

42.

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 (2012) 2-years outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 366:1686–1695PubMedCrossRef

Title: Development of a risk score for outcome after transcatheter aortic valve implantation
Authors: Moritz Seiffert
Jan-Malte Sinning
Alexander Meyer
Sandra Wilde
Lenard Conradi
Mariuca Vasa-Nicotera
Alexander Ghanem
Jörg Kempfert
Christoph Hammerstingl
Francisco M. Ojeda
Won-Keun Kim
Dietmar H. Koschyk
Johannes Schirmer
Stephan Baldus
Eberhard Grube
Helge Möllmann
Hermann Reichenspurner
Georg Nickenig
Stefan Blankenberg
Patrick Diemert
Hendrik Treede
Thomas Walther
Nikos Werner
Renate B. Schnabel
Publication date: 01-08-2014
Publisher: Springer Berlin Heidelberg
Published in: Clinical Research in Cardiology / Issue 8/2014
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-014-0692-4

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Conclusions

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