Transcatheter aortic valve replacement and vascular complications definitions

Nicolas M. Van Mieghem, Philippe Genereux, Robert M.A. Van Der Boon, Susheel Kodali, Stuart Head, Matthew Williams, Benoit Daneault, Arie Pieter Kappetein, Peter P. De Jaegere, Martin B. Leon, Patrick W. Serruys

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Aims: Transcatheter aortic valve replacement (TAVR) requires large calibre catheters and is therefore associated with increased vascular complications. The aim of this study was to illustrate the impact of the different definitions of major vascular complications on their incidence and to underscore the importance of uniform reporting. Methods and results: We pooled dedicated databases of consecutive patients undergoing TAVR from two tertiary care facilities and looked for the incidence of major vascular complications using various previously reported definitions. The level of agreement (Kappa statistic) between the respective definitions and the Valve Academic Research Consortium (VARC) consensus definition of vascular complications was assessed. A total of 345 consecutive patients underwent transfemoral TAVR and were included in this analysis. A completely percutaneous access and closure technique was applied in 96% of cases. Arterial sheath size ranged between 18 and 24 Fr, the majority being 18 Fr (60%). Procedural success was reached in 94.5%. Depending on the definition used, major vascular complications occurred in 5.2-15.9% of patients. According to the VARC definitions, the rate of major and minor vascular complications was 9.0% and 9.6%, respectively. Major vascular complications according to VARC criteria demonstrated at least a substantial level of agreement with the SOURCE registry (κ 0.80) , the UK registry (κ 0.82) the Italian registry (κ 0.72) and "FRANCE" registry (κ 0.70) definitions, compared to a moderate level of agreement with the definitions used in the German registry (κ 0.47) and the 18 Fr Safety and Efficacy study (κ 0.42). Minor complications according to VARC demonstrated a moderate agreement only with vascular complications using the German registry definition (κ 0.54). Conclusions: Non-uniformity in how vascular complications are defined precludes any reliable comparison between previously reported TAVR registries. The VARC consensus document offers standardised endpoint definitions and should be universally adopted to obtain better insights into global TAVR experience.

Original languageEnglish (US)
Pages (from-to)1317-1322
Number of pages6
JournalEuroIntervention
Volume9
Issue number11
DOIs
StatePublished - Jan 1 2014
Externally publishedYes

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Blood Vessels
Registries
Research
Transcatheter Aortic Valve Replacement
Incidence
Tertiary Healthcare
Catheters
Databases
Safety

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Van Mieghem, N. M., Genereux, P., Van Der Boon, R. M. A., Kodali, S., Head, S., Williams, M., ... Serruys, P. W. (2014). Transcatheter aortic valve replacement and vascular complications definitions. EuroIntervention, 9(11), 1317-1322. https://doi.org/10.4244/EIJV9I11A222
Van Mieghem, Nicolas M. ; Genereux, Philippe ; Van Der Boon, Robert M.A. ; Kodali, Susheel ; Head, Stuart ; Williams, Matthew ; Daneault, Benoit ; Kappetein, Arie Pieter ; De Jaegere, Peter P. ; Leon, Martin B. ; Serruys, Patrick W. / Transcatheter aortic valve replacement and vascular complications definitions. In: EuroIntervention. 2014 ; Vol. 9, No. 11. pp. 1317-1322.
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Van Mieghem, NM, Genereux, P, Van Der Boon, RMA, Kodali, S, Head, S, Williams, M, Daneault, B, Kappetein, AP, De Jaegere, PP, Leon, MB & Serruys, PW 2014, 'Transcatheter aortic valve replacement and vascular complications definitions', EuroIntervention, vol. 9, no. 11, pp. 1317-1322. https://doi.org/10.4244/EIJV9I11A222

Transcatheter aortic valve replacement and vascular complications definitions. / Van Mieghem, Nicolas M.; Genereux, Philippe; Van Der Boon, Robert M.A.; Kodali, Susheel; Head, Stuart; Williams, Matthew; Daneault, Benoit; Kappetein, Arie Pieter; De Jaegere, Peter P.; Leon, Martin B.; Serruys, Patrick W.

In: EuroIntervention, Vol. 9, No. 11, 01.01.2014, p. 1317-1322.

Research output: Contribution to journalArticle

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T1 - Transcatheter aortic valve replacement and vascular complications definitions

AU - Van Mieghem, Nicolas M.

AU - Genereux, Philippe

AU - Van Der Boon, Robert M.A.

AU - Kodali, Susheel

AU - Head, Stuart

AU - Williams, Matthew

AU - Daneault, Benoit

AU - Kappetein, Arie Pieter

AU - De Jaegere, Peter P.

AU - Leon, Martin B.

AU - Serruys, Patrick W.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Aims: Transcatheter aortic valve replacement (TAVR) requires large calibre catheters and is therefore associated with increased vascular complications. The aim of this study was to illustrate the impact of the different definitions of major vascular complications on their incidence and to underscore the importance of uniform reporting. Methods and results: We pooled dedicated databases of consecutive patients undergoing TAVR from two tertiary care facilities and looked for the incidence of major vascular complications using various previously reported definitions. The level of agreement (Kappa statistic) between the respective definitions and the Valve Academic Research Consortium (VARC) consensus definition of vascular complications was assessed. A total of 345 consecutive patients underwent transfemoral TAVR and were included in this analysis. A completely percutaneous access and closure technique was applied in 96% of cases. Arterial sheath size ranged between 18 and 24 Fr, the majority being 18 Fr (60%). Procedural success was reached in 94.5%. Depending on the definition used, major vascular complications occurred in 5.2-15.9% of patients. According to the VARC definitions, the rate of major and minor vascular complications was 9.0% and 9.6%, respectively. Major vascular complications according to VARC criteria demonstrated at least a substantial level of agreement with the SOURCE registry (κ 0.80) , the UK registry (κ 0.82) the Italian registry (κ 0.72) and "FRANCE" registry (κ 0.70) definitions, compared to a moderate level of agreement with the definitions used in the German registry (κ 0.47) and the 18 Fr Safety and Efficacy study (κ 0.42). Minor complications according to VARC demonstrated a moderate agreement only with vascular complications using the German registry definition (κ 0.54). Conclusions: Non-uniformity in how vascular complications are defined precludes any reliable comparison between previously reported TAVR registries. The VARC consensus document offers standardised endpoint definitions and should be universally adopted to obtain better insights into global TAVR experience.

AB - Aims: Transcatheter aortic valve replacement (TAVR) requires large calibre catheters and is therefore associated with increased vascular complications. The aim of this study was to illustrate the impact of the different definitions of major vascular complications on their incidence and to underscore the importance of uniform reporting. Methods and results: We pooled dedicated databases of consecutive patients undergoing TAVR from two tertiary care facilities and looked for the incidence of major vascular complications using various previously reported definitions. The level of agreement (Kappa statistic) between the respective definitions and the Valve Academic Research Consortium (VARC) consensus definition of vascular complications was assessed. A total of 345 consecutive patients underwent transfemoral TAVR and were included in this analysis. A completely percutaneous access and closure technique was applied in 96% of cases. Arterial sheath size ranged between 18 and 24 Fr, the majority being 18 Fr (60%). Procedural success was reached in 94.5%. Depending on the definition used, major vascular complications occurred in 5.2-15.9% of patients. According to the VARC definitions, the rate of major and minor vascular complications was 9.0% and 9.6%, respectively. Major vascular complications according to VARC criteria demonstrated at least a substantial level of agreement with the SOURCE registry (κ 0.80) , the UK registry (κ 0.82) the Italian registry (κ 0.72) and "FRANCE" registry (κ 0.70) definitions, compared to a moderate level of agreement with the definitions used in the German registry (κ 0.47) and the 18 Fr Safety and Efficacy study (κ 0.42). Minor complications according to VARC demonstrated a moderate agreement only with vascular complications using the German registry definition (κ 0.54). Conclusions: Non-uniformity in how vascular complications are defined precludes any reliable comparison between previously reported TAVR registries. The VARC consensus document offers standardised endpoint definitions and should be universally adopted to obtain better insights into global TAVR experience.

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Van Mieghem NM, Genereux P, Van Der Boon RMA, Kodali S, Head S, Williams M et al. Transcatheter aortic valve replacement and vascular complications definitions. EuroIntervention. 2014 Jan 1;9(11):1317-1322. https://doi.org/10.4244/EIJV9I11A222