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

Halkin, Amir; Steinvil, Arie; Witberg, Guy; Barsheshet, Alon; Barkagan, Michael; Assali, Abid; Segev, Amit; Fefer, Paul; Guetta, Victor; Barbash, Israel M.; Kornowski, Ran; Finkelstein, Ariel

doi:10.1016/j.ijcard.2016.04.038

Cited by 39 publications

(52 citation statements)

References 31 publications

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“…Our analysis of the UK TAVI registry has systematically demonstrated that outside their development cohorts, the German AV, FRANCE-2, OBSERVANT and ACC TAVI CPMs are miscalibrated and have low discrimination at predicting 30-day mortality. These results support previous work in this area 28 . In the current study, the FRANCE-2 and ACC models had the highest discrimination out of all those considered, with these comparing favorably to the internal validation results reported when these models were derived 14., 15..…”

Section: Discussionsupporting

confidence: 92%

Inadequacy of existing clinical prediction models for predicting mortality after transcatheter aortic valve implantation

Martin

Sperrin

Ludman

et al. 2017

American Heart Journal

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BackgroundThe performance of emerging transcatheter aortic valve implantation (TAVI) clinical prediction models (CPMs) in national TAVI cohorts distinct from those where they have been derived is unknown. This study aimed to investigate the performance of the German Aortic Valve, FRANCE-2, OBSERVANT and American College of Cardiology (ACC) TAVI CPMs compared with the performance of historic cardiac CPMs such as the EuroSCORE and STS-PROM, in a large national TAVI registry.MethodsThe calibration and discrimination of each CPM were analyzed in 6676 patients from the UK TAVI registry, as a whole cohort and across several subgroups. Strata included gender, diabetes status, access route, and valve type. Furthermore, the amount of agreement in risk classification between each of the considered CPMs was analyzed at an individual patient level.ResultsThe observed 30-day mortality rate was 5.4%. In the whole cohort, the majority of CPMs over-estimated the risk of 30-day mortality, although the mean ACC score (5.2%) approximately matched the observed mortality rate. The areas under ROC curve were between 0.57 for OBSERVANT and 0.64 for ACC. Risk classification agreement was low across all models, with Fleiss's kappa values between 0.17 and 0.50.ConclusionsAlthough the FRANCE-2 and ACC models outperformed all other CPMs, the performance of current TAVI-CPMs was low when applied to an independent cohort of TAVI patients. Hence, TAVI specific CPMs need to be derived outside populations previously used for model derivation, either by adapting existing CPMs or developing new risk scores in large national registries.

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Section: Discussionsupporting

confidence: 92%

Inadequacy of existing clinical prediction models for predicting mortality after transcatheter aortic valve implantation

Martin

Sperrin

Ludman

et al. 2017

American Heart Journal

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“…For instance, the AUC was reported to be 0.69 in the original validation cohort of the TAVR‐RS by the German authors and was 0.66 in our study . The STS PROM had an AUC of 0.60 in a recent study evaluating its predictive capability by Boehar et al, 0.68 in the IRRMA study, 0.76 in original validation cohort and found to be 0.52 in our study. However, the higher discriminatory power of TAVR‐RS over surgical scores demonstrated our analysis is largely in line with the previous studies …”

Section: Discussionsupporting

confidence: 66%

“…On the contrary, Israeli TAVR registry study had found that the risk score systems developed for TAVR (FRANCE2, OBSERVANT, and German AV score) were of limited accuracy. They failed to demonstrate superiority in determining the 30‐day post‐procedural mortality when compared to pre‐existing surgical score models.…”

Section: Discussionmentioning

confidence: 98%

“…The prevalence of frailty among patients undergoing TAVR has been reported as high as 80% . It is certainly possible that TAVR‐RS overlooks the of risk stratification process by predominantly focusing on objectively measured clinical variables, and perhaps the accuracy and prognostication of current models could be further improved by incorporation of comorbidities, frailty, and functional assessments, which have been validated as significant contributors to accurate assessment of early (30‐day) and late (1‐year) mortality. Parameters of 30‐day readmission and death have recently become a prominent adjunctive to healthcare networks ranking on a national level, measurement of quality of care, as well as reimbursement rates.…”

Section: Discussionmentioning

confidence: 99%

“…Variables included past medical history, baseline electrocardiogram, echocardiographic data, and laboratory studies. In accordance with the current Valve Academic Research Consortium‐2 (VARC‐2), the following major periprocedural adverse events were also collected and included: myocardial infarction, stroke, transient ischemic attack, acute kidney injury, conduction disturbance, arrhythmia, valve malpositioning, endocarditis, valve thrombosis, cardiac tamponade, vascular access site, and access‐related complications, such as vascular dissection, hematoma, or pseudoaneurysm …”

Section: Methodsmentioning

confidence: 99%

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Comparison of transcatheter aortic valve replacement risk score against currently accepted surgical risk models as predictors of 30‐day mortality in transcatheter aortic valve replacement

Yatsynovich

Khattak

Ali

et al. 2017

J Interven Cardiology

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Safety outcomes of new versus old generation transcatheter aortic valves

Finkelstein

Rozenbaum

Zhitomirsky

et al. 2018

Cathet Cardio Intervent

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Objective To compare procedural outcomes of transcatheter aortic valve implantation (TAVI) patients who were implanted with older versus newer generation valves. Background The current evidence base for improved safety of the newer commercially available TAVI valves is limited. Methods A retrospective analysis of the Israeli multicenter TAVI registry was performed. Patients were stratified by valve generation of four commercially available devices: Edwards Sapien (ESX) Edwards Sapien S3 (ES3), Medtronic CoreValve (MCV), and Medtronic Evolut R (MER). Results The cohort consisted of 737 patients with new generation valves (NGVs; ES3 n = 223; MER n = 514) and 1,869 with old generation valves (OGVs; MCV n = 1,181; ESX n = 688). Device success rates were significantly higher in NGV (97.5 versus 95.4%), with less post‐procedural paravalvular leak (3 versus 5.8%), and valve mal‐positioning (1.2 versus 3.4%); all P‐values<0.05. There were no differences in rates of permanent pacemaker implantation, stroke or acute kidney injury (AKI) of any stage between the groups, although stage ≥2 AKI was more prevalent in NGV. After adjustment to significant differences in baseline patient and procedural characteristics, device success was higher (OR 1.86, 95% confidence interval (CI) 1.09–3.18, P = 0.023) and the 1‐month safety outcome was significantly lower (OR 0.72, 95% CI 0.55–0.96, P = 0.025) for NGV. Device success was driven mainly by improved rates of PVL of ES3, while the safety outcome was mainly driven by improved rates of life‐threatening bleeding and valve mal‐positioning of MER. Conclusion As compared to OGV, use of NGV for TAVI was associated with higher rates of device success and lower rates of adverse events.

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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

Cited by 39 publications

References 31 publications

Inadequacy of existing clinical prediction models for predicting mortality after transcatheter aortic valve implantation

Inadequacy of existing clinical prediction models for predicting mortality after transcatheter aortic valve implantation

Comparison of transcatheter aortic valve replacement risk score against currently accepted surgical risk models as predictors of 30‐day mortality in transcatheter aortic valve replacement

Safety outcomes of new versus old generation transcatheter aortic valves

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