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

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

doi:10.1007/s00392-020-01731-9

Cited by 17 publications

(10 citation statements)

References 37 publications

(68 reference statements)

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“…This is particularly interesting if we consider the higher estimated surgical scores in these latter subgroups. Although mortality prediction of patients undergoing nonsurgical treatments is still evolving and surgical scores might have major limitations in this setting, 29 these results support the efficacy of HT in referring the patients to the appropriate treatment. Indeed, it seems that patients with acceptable risks have been identified and treated by cardiac surgery, whereas other patients (instead of undergoing surgery with predicted hazards) were referred to tailored management that often included transcatheter valve interventions and (in the case of coexistent IHD) percutaneous coronary revascularizations.…”

Section: Discussionmentioning

confidence: 69%

Clinical Impact of Heart Team Decisions for Patients With Complex Valvular Heart Disease: A Large, Single‐Center Experience

Burzotta

Graziani

Trani

et al. 2022

JAHA

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Background A multidisciplinary approach might be pivotal for the management of patients with valvular heart disease (VHD), but clinical outcome data are lacking. Methods and Results At our institution, since 2014, internal guidelines recommended heart team consultations for patients with VHD. The clinical/echocardiographic characteristics, treatment recommendations, performed treatment, and early clinical outcomes of consecutive, hospitalized patients with VHD undergoing heart team evaluation were collected. Surgical risk was prospectively assessed by the EuroSCORE II and STS‐PROM. The primary end point of the study was early mortality. A total of 1004 patients with VHD with high clinical complexity (mean age, 75 years; mean EuroSCORE II, 9.4%; mean STS‐PROM, 5.6%; 48% ischemic heart disease; 29% chronic kidney disease, 9% oncologic/hematologic diseases) were enrolled. The heart team recommended an interventional treatment for 807 (80%) patients and conservative management for 197 (20%) patients. Management crossovers occurred in only 5% of patients. The recommended intervention was cardiac surgery for 230 (23%) patients, percutaneous treatment in 516 (51%) patients, and hybrid treatment in 61 (6%) patients. Early mortality occurred in 24 patients (2.4%) and was independently predicted by aortic stenosis, left ventricular ejection fraction, pulmonary artery systolic pressure, and conservative management recommendation. In patients referred to treatment, observed early mortality (1.7%) was significantly lower ( P <0.001) than expected on the bases of both the STS‐PROM (5.2%) and EuroSCORE II (9.7%). Conclusions Within the limitations of its single‐center and observational design, the present study suggests that heart team–based management of patients with complex VHD is feasible and allows referral to a wide spectrum of interventions with promising early clinical results.

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Section: Discussionmentioning

confidence: 69%

Clinical Impact of Heart Team Decisions for Patients With Complex Valvular Heart Disease: A Large, Single‐Center Experience

Burzotta

Graziani

Trani

et al. 2022

JAHA

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“…Miscalibration in external-validation studies is common [12] , [13] , [14] , [15] . A common reason could be the improvement of care and/or procedural techniques that took place between the development time of the original MPMs and the time of external-validation.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, several TAVI-specific MPMs (such as FRANCE-2 and ACC-TAVI) have been developed for preoperative risk estimation [10] , [11] . These TAVI-specific MPMs were externally validated on different TAVI-populations [12] , [13] , [14] , [15] . The models FRANCE-2 and ACC-TAVI have been shown to outperform other validated MPMs on their discrimination performance.…”

Section: Introductionmentioning

confidence: 99%

Update and, internal and temporal-validation of the FRANCE-2 and ACC-TAVI early-mortality prediction models for Transcatheter aortic Valve Implantation (TAVI) using data from the Netherlands heart registration (NHR)

Al-Farra

Mol

Ravelli

et al. 2021

IJC Heart & Vasculature

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Background The predictive performance of the models FRANCE-2 and ACC-TAVI for early-mortality after Transcatheter Aortic Valve Implantation (TAVI) can decline over time and can be enhanced by updating them on new populations. We aim to update and internally and temporally validate these models using a recent TAVI-cohort from the Netherlands Heart Registration (NHR). Methods We used data of TAVI-patients treated in 2013–2017. For each original-model, the best update-method (model-intercept, model-recalibration, or model-revision) was selected by a closed-testing procedure. We internally validated both updated models with 1000 bootstrap samples. We also updated the models on the 2013–2016 dataset and temporally validated them on the 2017-dataset. Performance measures were the Area-Under ROC-curve (AU-ROC), Brier-score, and calibration graphs. Results We included 6177 TAVI-patients, with 4.5% observed early-mortality. The selected update-method for FRANCE-2 was model-intercept-update. Internal validation showed an AU-ROC of 0.63 (95%CI 0.62–0.66) and Brier-score of 0.04 (0.04–0.05). Calibration graphs show that it overestimates early-mortality. In temporal-validation, the AU-ROC was 0.61 (0.53–0.67). The selected update-method for ACC-TAVI was model-revision. In internal-validation, the AU-ROC was 0.63 (0.63–0.66) and Brier-score was 0.04 (0.04–0.05). The updated ACC-TAVI calibrates well up to a probability of 20%, and subsequently underestimates early-mortality. In temporal-validation the AU-ROC was 0.65 (0.58–0.72). Conclusion Internal-validation of the updated models FRANCE-2 and ACC-TAVI with data from the NHR demonstrated improved performance, which was better than in external-validation studies and comparable to the original studies. In temporal-validation, ACC-TAVI outperformed FRANCE-2 because it suffered less from changes over time.

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“…Volatile calibration performance is often observed in external risk model validation studies: both NCDR models were externally validated in a Japanese patient cohort with over 11,000 patients [29], with similarly good discrimination performance, but also offsets in calibration [29]. Previous work from our group also observed corrupted calibration [10,30]. The methodical work of Matheny et al [31] shows that volatile calibration in risk models in interventional cardiology is related to small changes in event risk and data assessment, while retained discrimination shows the stability of risk factors over time.…”

Section: Risk Model Calibration (Fig 2 and Table 3)mentioning

confidence: 84%

National Cardiovascular Data Registry-Acute Kidney Injury (NCDR) vs. Mehran risk models for prediction of contrast-induced nephropathy and need for dialysis after coronary angiography in a German patient cohort

et al. 2021

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Background Contrast-induced nephropathy (CIN) is a major adverse event in patients undergoing coronary angiography. The Mehran risk model is the gold-standard for CIN risk prediction. However, its performance in comparison to more contemporary National Cardiovascular Data Registry-Acute Kidney Injury (NCDR-AKI) risk models remains unknown. We aimed to compare both in this study. Methods and results Predictions of Mehran and NCDR-AKI risk models and clinical events of CIN and need for dialysis were assessed in a total of 2067 patients undergoing coronary angiography with or without percutaneous coronary intervention. Risk models were compared regarding discrimination (receiver operating characteristic analysis), net reclassification improvement (NRI) and calibration (graphical and statistical analysis). The NCDR risk model showed superior risk discrimination for predicting CIN (NCDR c-index 0.75, 95% CI 0.72–0.78; vs. Mehran c-index 0.69, 95% CI 0.66–0.72, p < 0.01), and continuous NRI (0.22; 95% CI 0.12–0.32; p < 0.01) compared to the Mehran model. The NCDR risk model tended to underestimate the risk of CIN, while the Mehran model was more evenly calibrated. For the prediction of need for dialysis, NCDR-AKI-D also discriminated risk better (c-index 0.85, 95% CI 0.79–0.91; vs. Mehran c-index 0.75, 95% CI 0.66–0.84; pNCDRvsMehran < 0.01), but continuous NRI showed no benefit and calibration analysis revealed an underestimation of dialysis risk. Conclusion In German patients undergoing coronary angiography, the modern NCDR risk model for predicting contrast-induced nephropathy showed superior discrimination compared to the GRACE model while showing less accurate calibration. Results for the outcome ‘need for dialysis’ were equivocal. Graphic abstract

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

Cited by 17 publications

References 37 publications

Clinical Impact of Heart Team Decisions for Patients With Complex Valvular Heart Disease: A Large, Single‐Center Experience

Clinical Impact of Heart Team Decisions for Patients With Complex Valvular Heart Disease: A Large, Single‐Center Experience

Update and, internal and temporal-validation of the FRANCE-2 and ACC-TAVI early-mortality prediction models for Transcatheter aortic Valve Implantation (TAVI) using data from the Netherlands heart registration (NHR)

National Cardiovascular Data Registry-Acute Kidney Injury (NCDR) vs. Mehran risk models for prediction of contrast-induced nephropathy and need for dialysis after coronary angiography in a German patient cohort

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