Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation Clinical Trials

Leon, Martin B.; Piazza, Nicolò; Nikolsky, Eugenia; Blackstone, Eugene H.; Cutlip, Donald E.; Kappetein, Arie Pieter; Krucoff, Mitchell W.; Mack, Michael J.; Mehran, Roxana; Miller, D. Craig; Morel, Marie‐Angèle; Petersen, John L.; Popma, Jeffrey J.; Takkenberg, Johanna J.M.; Vahanian, Alec; Es, Gerrit‐Anne van; Vranckx, Pascal; Webb, John G.; Windecker, Stephan; Serruys, Patrick W.

doi:10.1016/j.jacc.2010.12.005

Cited by 712 publications

(138 citation statements)

References 157 publications

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“…The cutoff to define procedural myocardial injury post‐TAVI increased form 10× ULN in the VARC consensus document19 to 15× ULN in the VARC‐2 definition,11 largely based on the study by Rodes‐Cabau et al., who found that this higher cutoff better predicted adverse outcomes 5. By associating cTnT elevation >15× ULN with 10‐fold higher mortality at 30 days and 2‐fold increased mortality at 2 years, the present study supports the current VARC‐2 definition as a clinically meaningful, prognostically relevant cutoff of post‐TAVI cTn increase.…”

Section: Discussionmentioning

confidence: 99%

Post‐Procedural Troponin Elevation and Clinical Outcomes Following Transcatheter Aortic Valve Implantation

Koskinas

Stortecky

Franzone

et al. 2016

JAHA

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BackgroundBiomarkers of myocardial injury increase frequently during transcatheter aortic valve implantation (TAVI). The impact of postprocedural cardiac troponin (cTn) elevation on short‐term outcomes remains controversial, and the association with long‐term prognosis is unknown.Methods and ResultsWe evaluated 577 consecutive patients with severe aortic stenosis treated with TAVI between 2007 and 2012. Myocardial injury, defined according to the Valve Academic Research Consortium (VARC)‐2 as post‐TAVI cardiac troponin T (cTnT) >15× the upper limit of normal, occurred in 338 patients (58.1%). In multivariate analyses, myocardial injury was associated with higher risk of all‐cause mortality at 30 days (adjusted hazard ratio [HR], 8.77; 95% CI, 2.07–37.12; P=0.003) and remained a significant predictor at 2 years (adjusted HR, 1.98; 95% CI, 1.36–2.88; P<0.001). Higher cTnT cutoffs did not add incremental predictive value compared with the VARC‐2–defined cutoff. Whereas myocardial injury occurred more frequently in patients with versus without coronary artery disease (CAD), the relative impact of cTnT elevation on 2‐year mortality did not differ between patients without CAD (adjusted HR, 2.59; 95% CI, 1.27–5.26; P=0.009) and those with CAD (adjusted HR, 1.71; 95% CI, 1.10–2.65; P=0.018; P for interaction=0.24). Mortality rates at 2 years were lowest in patients without CAD and no myocardial injury (11.6%) and highest in patients with complex CAD (SYNTAX score >22) and myocardial injury (41.1%).Conclusions VARC‐2–defined cTnT elevation emerged as a strong, independent predictor of 30‐day mortality and remained a modest, but significant, predictor throughout 2 years post‐TAVI. The prognostic value of cTnT elevation was modified by the presence and complexity of underlying CAD with highest mortality risk observed in patients combining SYNTAX score >22 and evidence of myocardial injury.

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Section: Discussionmentioning

confidence: 99%

Post‐Procedural Troponin Elevation and Clinical Outcomes Following Transcatheter Aortic Valve Implantation

Koskinas

Stortecky

Franzone

et al. 2016

JAHA

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“…In 2011, VARC addressed this unmet scientific need and provided a consensus document with expert recommendations for a unified endpoint assessment after TAVI 12. VARC endpoint definitions have been rapidly adopted in the scientific community and currently serve as a reproducible and standardized tool to compare hemodynamic and clinical results post‐TAVI in routine clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…Although early TAVI reports varied considerably in terms of frequency and type of complications owing to the lack of standardized endpoint definitions,9, 10, 11 this was successfully addressed by the Valve Academic Research Consortium (VARC) in 2011 12. The first VARC consensus document aimed to harmonize endpoint definitions in TAVI trials and registries and provide guidance for uniform and standardized reporting of clinical outcomes.…”

Section: Introductionmentioning

confidence: 99%

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Stortecky

Pilgrim

Heg³

et al. 2015

JAHA

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BackgroundThe Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions.Methods and ResultsBetween August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern‐TAVI‐Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870).ConclusionsThe VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification.

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“…Roughly half of the patients with an LVEF <50% had an LVEDD ≥ 55 mm (53.0% in the TAVR group and 48.4% in the SAVR group, p = 0.600). There were significantly more patients with a large LVEDD (≥ 55 mm) in the low EF group as compared to those with preserved EF (53.0% vs. 13 ; p = 0.013) ( Table 1). Since the number of patients with available echocardiography data varied at each time point due to missing measurements or patient deaths, we also evaluated paired data in the subset of patients with an EF ≥ 50% (139 TAVR and 72 SAVR patients) who had LV mass data available at baseline, discharge, 1 month, and 1 year.…”

Section: Change In Calculated LV Mass After Avrmentioning

confidence: 99%

“…12 Assessment of the native AV and the bioprosthesis were made according to the original Valve Academic Research Consortium, American Society of Echocardiography, and European Association of Echocardiography. 13,14 LV mass was derived from the established formula (Devereux and colleagues 15 ) as follows:…”

Section: Echocardiographymentioning

confidence: 99%

A Paradox between LV Mass Regression and Hemodynamic Improvement after Surgical and Transcatheter Aortic Valve Replacement

et al. 2017

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Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation Clinical Trials

Cited by 712 publications

References 157 publications

Post‐Procedural Troponin Elevation and Clinical Outcomes Following Transcatheter Aortic Valve Implantation

Post‐Procedural Troponin Elevation and Clinical Outcomes Following Transcatheter Aortic Valve Implantation

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

A Paradox between LV Mass Regression and Hemodynamic Improvement after Surgical and Transcatheter Aortic Valve Replacement

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