Predicting 5-Year Clinical Outcomes After Transcatheter or Surgical Aortic Valve Replacement (a Risk Score from the SURTAVI Trial)

Abstract

Risk prediction scores for long-term outcomes after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) are lacking. This study aimed to develop preprocedural risk scores for 5-year clinical outcomes after TAVI or SAVR. This analysis included 1,660 patients at an intermediate surgical risk with severe aortic stenosis randomly assigned to TAVI (n = 864) or SAVR (n = 796) from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial. The primary end point was a composite of all-cause mortality or disabling stroke at 5 years. The secondary end point was a composite of cardiovascular mortality or hospitalizations for valve disease or worsening heart failure at 5 years. Preprocedural multivariable predictors of clinical outcomes were used to calculate a simple risk score for both procedures. At 5 years, the primary end point occurred in 31.3% of the patients with TAVI and 30.8% of the patients with SAVR. Preprocedural predictors differed between TAVI and SAVR. Baseline anticoagulant use was a common predictor for events in both procedures, whereas male sex and a left ventricular ejection fraction <60% were significant predictors for events in patients with TAVI and SAVR, respectively. A total of 4 simple scoring systems were created based on these multivariable predictors. The C-statistics of all models were modest but performed better than the contemporary risk scores. In conclusion, preprocedural predictors of events differ between TAVI and SAVR, necessitating separate risk models. Despite the modest predictive value of the SURTAVI risk scores, they appeared superior to other contemporary scores. Further research is needed to strengthen and validate our risk scores, possibly by including biomarker and echocardiographic parameters. Risk prediction scores for long-term outcomes after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) are lacking. This study aimed to develop preprocedural risk scores for 5-year clinical outcomes after TAVI or SAVR. This analysis included 1,660 patients at an intermediate surgical risk with severe aortic stenosis randomly assigned to TAVI (n = 864) or SAVR (n = 796) from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial. The primary end point was a composite of all-cause mortality or disabling stroke at 5 years. The secondary end point was a composite of cardiovascular mortality or hospitalizations for valve disease or worsening heart failure at 5 years. Preprocedural multivariable predictors of clinical outcomes were used to calculate a simple risk score for both procedures. At 5 years, the primary end point occurred in 31.3% of the patients with TAVI and 30.8% of the patients with SAVR. Preprocedural predictors differed between TAVI and SAVR. Baseline anticoagulant use was a common predictor for events in both procedures, whereas male sex and a left ventricular ejection fraction <60% were significant predictors for events in patients with TAVI and SAVR, respectively. A total of 4 simple scoring systems were created based on these multivariable predictors. The C-statistics of all models were modest but performed better than the contemporary risk scores. In conclusion, preprocedural predictors of events differ between TAVI and SAVR, necessitating separate risk models. Despite the modest predictive value of the SURTAVI risk scores, they appeared superior to other contemporary scores. Further research is needed to strengthen and validate our risk scores, possibly by including biomarker and echocardiographic parameters. Transcatheter aortic valve implantation (TAVI) has become an alternative to surgical aortic valve replacement (SAVR) for the treatment of severe symptomatic aortic stenosis (AS) in patients of all surgical risk levels. As survival rates after TAVI increase and as indications are shifting to younger patients with lower risk, it has become more important to develop predictive tools focused on longer-term outcomes. Preprocedural risk prediction models can guide the decision for whether a patient should undergo TAVI or SAVR and can help in the expectation management for both patients and clinicians. Traditional scores such as the Society of Thoracic Surgery (STS) Predicted Risk of Mortality (STS-PROM) score or the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II have been developed to predict periprocedural mortality for surgical procedures.1O'Brien SM Feng L He X Xian Y Jacobs JP Badhwar V Kurlansky PA Furnary AP Cleveland Jr, JC Lobdell KW Vassileva C Wyler von Ballmoos MC Thourani VH Rankin JS Edgerton JR D'Agostino RS Desai ND Edwards FH Shahian DM The Society of Thoracic Surgeons 2018 adult cardiac surgery risk models: part 2—statistical methods and results.Ann Thorac Surg. 2018; 105: 1419-1428Abstract Full Text Full Text PDF PubMed Google Scholar,2Nashef SAM Roques F Sharples LD Nilsson J Smith C Goldstone AR Lockowandt U. EuroSCORE II. Eur J Cardiothorac Surg. 2012; 41: 734-744Crossref PubMed Scopus (1889) Google Scholar As such, they have suboptimal performance when applied to TAVI populations and have poor discrimination for longer-term outcomes.1O'Brien SM Feng L He X Xian Y Jacobs JP Badhwar V Kurlansky PA Furnary AP Cleveland Jr, JC Lobdell KW Vassileva C Wyler von Ballmoos MC Thourani VH Rankin JS Edgerton JR D'Agostino RS Desai ND Edwards FH Shahian DM The Society of Thoracic Surgeons 2018 adult cardiac surgery risk models: part 2—statistical methods and results.Ann Thorac Surg. 2018; 105: 1419-1428Abstract Full Text Full Text PDF PubMed Google Scholar,3Shahian DM Jacobs JP Badhwar V Kurlansky PA Furnary AP Cleveland Jr, JC Lobdell KW Vassileva C Wyler von Ballmoos MC Thourani VH Rankin JS Edgerton JR D'Agostino RS Desai ND Feng L He X O'Brien SM The Society of Thoracic Surgeons 2018 adult cardiac surgery risk models: part 1—background, design considerations, and model development.Ann Thorac Surg. 2018; 105: 1411-1418Abstract Full Text Full Text PDF PubMed Google Scholar, 4Vahanian A Beyersdorf F Praz F Milojevic M Baldus S Bauersachs J Capodanno D Conradi L De Bonis M De Paulis R Delgado V Freemantle N Gilard M Haugaa KH Jeppsson A Jüni P Pierard L Prendergast BD Sádaba JR Tribouilloy C Wojakowski W ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease.Eur Heart J. 2022; 43: 561-632Crossref PubMed Scopus (1060) Google Scholar, 5Wang TK Choi DH Haydock D Gamble G Stewart R Ruygrok P. Comparison of Risk Scores for Prediction of Complications following aortic valve replacement.Heart Lung Circ. 2015; 24: 595-601Abstract Full Text Full Text PDF PubMed Google Scholar, 6Baro R Cura F Belardi J Brugaletta S Lamelas P. Surgical risk scoring in TAVI: still needed? A metaregression analysis.Curr Probl Cardiol. 2021; 46100875Crossref Scopus (2) Google Scholar In addition, contemporary scores include several variables and therefore are not always easy and practical to use in daily clinical practice. Few studies on risk predictors in patients who underwent TAVI have recently been published. However, relatively small cohorts or only patients with low-flow, low-gradient AS have been included.7Penso M Pepi M Fusini L Muratori M Cefalù C Mantegazza V Gripari P Ali SG Fabbiocchi F Bartorelli AL Caiani EG Tamborini G. Predicting long-term mortality in TAVI patients using machine learning techniques.J Cardiovasc Dev Dis. 2021; 8: 44Crossref PubMed Google Scholar,8Ludwig S Goßling A Seiffert M Westermann D Sinning JM Sugiura A Adam M Mauri V Frank D Seoudy H Rudolph T Potratz M Conradi L Schofer N. Risk prediction in patients with low-flow, low-gradient aortic stenosis and reduced ejection fraction undergoing TAVI.Open Heart. 2022; 9e001912Crossref PubMed Scopus (4) Google Scholar The SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial randomly allocated patients with symptomatic severe AS who were at an intermediate surgical risk to either self-expanding, supra-annular TAVI, or SAVR. In the present analysis, we aimed to develop simple SURTAVI risk scores based on the preprocedural variables to effectively stratify risk at 5 years after TAVI or SAVR. The SURTAVI trial details, including the inclusion and have been L M DH H S T J R W N M S R JS J H Y AS AP SURTAVI or transcatheter replacement in J PubMed Scopus Google Scholar In 1,660 patients with severe symptomatic severe AS who were to at an intermediate risk to by a based on the score and other underwent TAVI with a or R or SAVR were from to at in and the The SURTAVI trial the of the of and or the trial and all patients were performed at and and 5 years after the clinical events all the clinical events and an the at and and and 5 G D L J J Y M DH of aortic and of transcatheter aortic an from the Cardiovasc 2015; 8: PubMed Scopus Google Scholar The preprocedural clinical echocardiographic and used to the risk scores were from the and on the and The primary end point of analysis was the composite of all-cause mortality or disabling stroke at 5 years. The secondary end point was the composite of cardiovascular mortality or for aortic valve disease or worsening heart failure at 5 years. of both end can in the SURTAVI 5-year L S H M JC W JS W J S R N DH S SURTAVI transcatheter surgical aortic valve replacement in 5-year outcomes of the SURTAVI clinical Cardiol. 2022; PubMed Scopus Google Scholar primary analysis included patients who underwent an TAVI or SAVR variables are as and and using the or variables are as and using the A analysis was performed using the for the TAVI and SAVR cohorts and for study end The of the variables included in the model was based on clinical and included preprocedural and clinical and echocardiographic parameters. with were not and The multivariable model was using the to the variables in the analysis with the performance were the score easy to use in the clinical not a total of 5 variables were The models were by from the to the and the model was to the with the for the TAVI and SAVR cohorts and for study end The models were used to calculate the SURTAVI risk scores based on a of the with of the predictor The risk were as and and for study end point and patient were by risk The performance of the SURTAVI risk scores were with and with the were The were significant when the the in were performed using the and R The SURTAVI 5-year outcomes have been L S H M JC W JS W J S R N DH S SURTAVI transcatheter surgical aortic valve replacement in 5-year outcomes of the SURTAVI clinical Cardiol. 2022; PubMed Scopus Google Scholar A total of 1,660 patients underwent an TAVI (n = 864) or SAVR (n = The was years, were and the was The clinical 5-year was for (n = of the patients with TAVI and (n = of the patients with SAVR The echocardiographic 5-year was for (n = and (n = of patients with TAVI and SAVR, respectively. At 5 years of the primary end point occurred in 31.3% (n = of patients with TAVI and 30.8% (n = of patients with SAVR to = In the TAVI of the patients (n = with (n = in the surgery to = and of the patients who underwent TAVI (n = (n = of who underwent surgery a disabling stroke to = mortality was between TAVI (n = SAVR (n = = for aortic valve disease or worsening heart failure at 5 years occurred in (n = of the patients with TAVI and (n = of the patients with SAVR = L S H M JC W JS W J S R N DH S SURTAVI transcatheter surgical aortic valve replacement in 5-year outcomes of the SURTAVI clinical Cardiol. 2022; PubMed Scopus Google Scholar Baseline clinical and echocardiographic of patients with and the primary end point are in and with and the secondary end point in The preprocedural predictors of the primary and secondary end are in 4 and of TAVI and SAVR patients with and the primary mortality or disabling stroke at 5 of heart 5 or in as or of patients = aortic = aortic valve = aortic valve = = = = = left ventricular ejection = = Heart = = = in a as or of patients AR = aortic = aortic valve = aortic valve = = = = = left ventricular ejection = = Heart = = = The preprocedural with the primary end point are in The significant predictors in the TAVI male sex to = disease to = 5 or to and anticoagulant use to The model included a of in the of all other was with a lower risk of the primary end not significant to = predictors of the primary and secondary mortality or disabling stroke at 5 or in mortality or for valve disease or worsening heart failure at 5 = aortic valve = = = = left ventricular ejection = Heart in a = aortic valve = = = = left ventricular ejection = Heart The following were with the primary end point for patients with to = in the to = use to anticoagulant use to and left ventricular ejection fraction <60% to = The preprocedural with the secondary end point are in The significant predictors in the TAVI male sex to = to = to and a aortic valve to = In addition, in the of all other was with a lower risk of the secondary end point in patients with TAVI to = The following were with the secondary end point for patients with Heart to = disease to = to anticoagulant use to and <60% to = on the from the 5 predictors and patient a risk score was performed The risk score for the primary end point was for patients with TAVI and for patients with SAVR. the secondary end the risk score was for patients with TAVI and for patients with SAVR. The SURTAVI risk score effectively patients who were at risk risk to and risk of the primary end point and secondary end The for the primary end point was to for patients with TAVI and to for patients with SAVR. The for the secondary end point was to for patients with TAVI and to for patients with risk score mortality or disabling stroke at 5 5 or in mortality or for valve disease or worsening heart failure at 5 = aortic valve = = = left ventricular ejection = Heart in a = aortic valve = = = left ventricular ejection = Heart The of the score for the primary end point was to for patients with TAVI and to for patients with SAVR. The of the score for the secondary end point was to for patients with TAVI and to for patients with SAVR. The for the risk score and the score can in 4 the for the SURTAVI risk and EuroSCORE for the all-cause mortality at years and the of our study is the to develop a risk score for patients with TAVI and SAVR using preprocedural with long-term The of are as preprocedural predictors of 5-year outcomes after TAVI and SAVR the of risk scores. (2) Baseline anticoagulant use was a common predictor of events in patients with TAVI and SAVR. sex was a common predictor for outcomes in patients with TAVI, whereas a <60% was a common predictor for outcomes in patients with SAVR. (4) risk models a modest predictive value but were more than other risk scores. in the SURTAVI trial were for either TAVI or SAVR and an intermediate surgical However, to our analysis, the of the outcomes differ between the TAVI and SAVR procedures. This the of risk scores for TAVI and SAVR populations help patients at a risk after aortic valve replacement was a common predictor for the primary end point after TAVI and SAVR and for the secondary end point after SAVR. In a were predictive for outcomes after TAVI in the transcatheter aortic valve KH S C D AS J T P P A G N C D G MC C P MC A anticoagulant use is with cardiovascular events in after transcatheter aortic valve an analysis from the J Cardiol. Full Text Full Text PDF PubMed Scopus (2) Google Scholar This the use of at an for patients with more and therefore poor outcomes. The indications for anticoagulant use in patients who underwent include stroke in patients with and disease or of A G N D N JS M N M J C N A P P A M for the and of of the European Society of Guidelines on the and management of in Eur Heart J in Eur Heart J Heart J. Google G M M in patients undergoing transcatheter aortic valve and Heart J. Google Scholar these were not as predictors. This on these variables as a predictor but are when in the of anticoagulant can the risk of with anticoagulant to mortality H A T F M S A analysis of the predictors of after transcatheter aortic valve using the 2021; Google J W Y N X Y Risk for to the and of the on A J Cardiol. Full Text Full Text PDF PubMed Scopus Google Scholar The of the can to an risk of such as and therefore The of Transcatheter Aortic Valve Implantation) trial the of the sex was with the primary and secondary outcomes in patients with TAVI has become the outcomes after TAVI differ between are and on the M A A L R P L A M R M A F Jr, F TAVI on long-term outcomes of patients undergoing transcatheter aortic valve Cardiovasc PubMed Scopus Google S D KH M L Thourani VH M at and outcomes patients undergoing transcatheter aortic valve a PubMed Scopus Google Scholar In a all-cause mortality risk after TAVI than P T A J T N P JC A F A A T L following aortic stenosis treatment surgical in a J Cardiol. 2021; Full Text Full Text PDF PubMed Scopus (2) Google G H Frank D S Rudolph T R C T mortality in and after transcatheter aortic valve implantation using the Cardiovasc 2021; PubMed Scopus Google Scholar A can the in and a risk between TAVI, such as rates of and in A M AS M C C L M G N V M L G C A C M D C F after transcatheter aortic valve replacement from the clinical Cardiovasc Dev Dis. 2021; 8: PubMed Scopus Google Scholar In a a survival was in who better outcomes with SAVR, but was not in C C M P. in aortic valve is surgical aortic valve replacement and transcatheter aortic valve replacement in than in Thorac Dis. PubMed Scopus Google Scholar A of and to TAVI N A S J P N P G R A A P J AS MC C MC A survival from transcatheter aortic valve implantation surgical aortic valve of the of including J Cardiol. 2018; Full Text Full Text PDF PubMed Scopus Google Scholar The for is a still of have better outcomes after TAVI, but the male sex as an predictor for outcomes has not been in a A and studies in patients with AS help in more A <60% was with the primary and secondary end in patients with SAVR A reduced has been as a predictor for outcomes after SAVR in JS of left ventricular ejection fraction on in patients with severe aortic stenosis undergoing aortic valve Cardiovasc 2015; PubMed Scopus Google S PA left ventricular ejection fraction in patients with aortic Cardiol. 2018; Scopus Google Scholar to a study randomly allocated patients to TAVI SAVR, patients with a outcomes after TAVI, to lower mortality S G J DH M J of stroke and left ventricular ejection fraction on mortality after aortic valve Full Text Full Text PDF PubMed Scopus (4) Google Scholar However, in the patients with a reduced the of treatment not the mortality A in ejection fraction can a of AS and AS to left ventricular and to ventricular it in a in and S PA left ventricular ejection fraction in patients with aortic Cardiol. 2018; Scopus Google Scholar In the European Society of an in patients with AS is an for A Beyersdorf F Praz F Milojevic M Baldus S Bauersachs J Capodanno D Conradi L De Bonis M De Paulis R Delgado V Freemantle N Gilard M Haugaa KH Jeppsson A Jüni P Pierard L Prendergast BD Sádaba JR Tribouilloy C Wojakowski W ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease.Eur Heart J. 2022; 43: 561-632Crossref PubMed Scopus (1060) Google Scholar patients with reduced ejection fraction for study an <60% a poor discrimination for patients with TAVI, but it appeared to with rates after SAVR. research is needed to A was with the secondary end point in patients with TAVI, A Beyersdorf F Praz F Milojevic M Baldus S Bauersachs J Capodanno D Conradi L De Bonis M De Paulis R Delgado V Freemantle N Gilard M Haugaa KH Jeppsson A Jüni P Pierard L Prendergast BD Sádaba JR Tribouilloy C Wojakowski W ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease.Eur Heart J. 2022; 43: 561-632Crossref PubMed Scopus (1060) Google Scholar The inclusion in the SURTAVI trial were SAM Roques F Sharples LD Nilsson J Smith C Goldstone AR Lockowandt U. EuroSCORE II. Eur J Cardiothorac Surg. 2012; 41: 734-744Crossref PubMed Scopus (1889) Google Scholar or and or L M DH H S T J R W N M S R JS J H Y AS AP SURTAVI or transcatheter replacement in J PubMed Scopus Google Scholar The was between the and in TAVI, but the was in the This a and in the and were included as variables in the was not The or was a predictor for events after TAVI, whereas in was a predictor for events after SAVR. This tools predict events after both procedures. In these tools a in the treatment and to to studies the of these tools in prediction after either TAVI or SAVR, but a between both has not been with the J AR C Y DH of in from transcatheter surgical aortic valve Cardiovasc 2021; Scopus Google Scholar, J A JM R J S JS Shahian D mortality after transcatheter aortic valve from the Society of Thoracic of transcatheter Valve PubMed Scopus Google Scholar, H M Y T T of and and mortality after transcatheter aortic valve Cardiol. Full Text Full Text PDF PubMed Scopus (4) Google Scholar should to the tools in the risk for TAVI SAVR. The C-statistics of the SURTAVI risk scores a discrimination and an performance the predictive value of the SURTAVI risk scores to superior to several of the contemporary periprocedural risk scores, such as the and M of clinical prediction models for mortality after transcatheter aortic valve Heart J. 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The of such risk scores can help in clinical decision for heart and for as a common of poor 5-year outcomes after TAVI and SAVR. The value of simple and SURTAVI risk score can by the of more echocardiographic and biomarker parameters. Further in cohorts is has from has from Edwards and and from and or to the from Edwards as of the of by Edwards and but has not by or He is of the of several by on and from as a for and is an and of is an and of on an for and has from Edwards and has from has to from for and has of to an of the of the and the of the an of analysis with with with with with with with with with with

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