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
ABSTRACT Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or "inoperable" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS.
The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System.
All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively.
Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% +/- 13.9% vs STS 6.7% +/- 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES > or =15%, 16% had an STS > or =10%, and 40% had an LES > or =20% or STS > or =10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration.
Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.
- SourceAvailable from: Arie Pieter Kappetein
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- "These models were developed and validated in a standard surgical risk population. The predictive power of both models is therefore suboptimal in high-risk patients with valvular disease, although the STS score has shown to outperform the Logistic EuroSCORE . These models are even more limited in application to patients who are considered at prohibitive risk for cardiac surgery, a cohort that could particularly benefit from TAVI. "
ABSTRACT: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery 10/2012; 42(5):S45-60. DOI:10.1093/ejcts/ezs533 · 2.81 Impact Factor
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ABSTRACT: Storia Il primo impianto di protesi aortica per via percutanea della valvola CoreValve ReValving System (CoreValve Inc., Irvine, CA, USA) è stato effettuato da J. La Borde e da E. Grube nel 2004 (1-4) . Il sistema CoreValve ReValving System è una protesi costituita, in quella di prima gene-razione, da lembi di pericardio bovino successivamente sostituiti con pericardio porcino montati su uno stent di nitinolo autoespandibile (Fig. 1). Essa è disponibile in due misure, 26 e 29 mm di inflow, e viene introdotta per via transarteriosa (femorale o succlavia) mediante intro-duttore 18F (protesi di III generazione) (Fig. 1). Dal 2004 il sistema ha avuto continui e costanti progressi tecnologici soprattutto nel sistema di rilascio che da un calibro di 25F è stato ridotto a 18F (prossimamente a 16F) per cui la procedura inizialmente eseguita in aneste-sia generale, con il sistema di assistenza Tandem Heart e con isolamento chirurgico dell'accesso arterioso attual-mente è una procedura eseguibile totalmente per approc-cio percutaneo senza assistenza circolatoria e in anestesia locale con paziente sveglio o in blanda sedazione (5,6) . Selezione del paziente La selezione del paziente è certamente il momento fonda-mentale per l'indicazione corretta e il risultato immediato della procedura (1,4,6-10) . Essa consta di varie fasi come l'analisi della morfologia della valvola aortica, lo studio dell'aorta toracica e soprattutto degli accessi vascolari arteriosi. Un'adeguata valutazione permette di ridurre al minimo il rischio di complicanze peri-e postprocedurali.
- The Journal of thoracic and cardiovascular surgery · 3.99 Impact Factor